Kornimate/medical-research-clean huggingface dataset:
effects of nasal high-flow oxygen in patients with an exacerbation of chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the investigators are looking at the effect of humidified nasal high-flow with oxygen (hnhf-o2) on air exchange during exacerbations of copd. hnhf-o2 therapy may have beneficial effects in patients with severe breathing impairment that results in low oxygen in the blood. some studies show that patients with low blood oxygen levels who use hfnc oxygen have lower rates of needing mechanical ventilation.

patients admitted to the hospital with an exacerbation of copd accompanied by respiratory failure need supplemental oxygen and alleviation of an increased work of breathing. patients with acute exacerbations of copd have hypoxemia, hypercapnia and an elevated work of breathing due to increased airways obstruction and hyperinflation. patient outcomes can be improved by aggressive bronchodilation and systemic corticosteroids, but methods that can augment spontaneous ventilation and decrease the work of breathing can help avoid intubation. high flow nasal cannula (hfnc) has been shown to be useful in patients with severe hypoxemic respiratory failure and those recently extubated from mechanical ventilation. hfnc provides warmed and humidified high flow (10-60l/min) by nasal cannula that allows precise titration of % inspired fio2 in the air/oxygen blend. the airvo 2 device delivers warmed and humidified respiratory gases to spontaneously breathing patients using a humidifier and integrated flow generator. in this study, the air/ oxygen gas blend (20-35l/min) will be administered by the airvo 2 hnhf device to achieve an fraction of inspired oxygen (fio2) \> 90% at rest. a potential advantage of the airvo 2 hnhf device includes the ability of the device to deliver oxygen that has been warmed and humidified. also, the high flow rates achieved with this device may reduce the work of breathing. this is an open-labeled pilot study of ten patients to determine the safety and feasibility of using the device in the management of patients with an acute exacerbation of copd with acute on chronic respiratory failure.

Eligibility criteria:
inclusion criteria: * males and females 40 years of age or older * hospitalized for an acute exacerbation of copd on the 6th floor of rock pavilion (pulmonary inpatient service) * smoking history of \> 10 pack-years * paco2 ≥ 45 mm hg * able to provide informed consent * willing to participate in daily measurements of arterial blood gases, completion of study questionnaires, and other study-related procedures exclusion criteria: * upper airway or nasal problems that prohibit the use of humidified high-flow nasal oxygen * hemodynamic instability defined as the need for blood pressure or blood volume support to maintain adequate tissue perfusion and oxygenation * urgent need for endotracheal intubation * a do-not-intubate order * a known diagnosis of obstructive sleep apnea * present use of continuous positive airway pressure (cpap) or bilevel positive airway pressure (bipap) therapy

Keywords: therapy noninvasive ventilation
autologous skin substitute for chronic leg/foot ulcers.

Conditions: Varicose Ulcer

Summary: a prospective, multicenter, randomised controlled phase ii study in which patients with therapy resistant (arterio-) venous leg/foot ulcers are treated with tiscover® (test group) or with as210 (control group) to determine the safety and relative efficacy of both products.

multicenter, randomised clinical trial in out patient in which patients with chronic (arterio-) venous leg/foot ulcers are treated with an autologous cultured human living skin substitute (tiscover®: test group) or with acellular donor dermis (as210: control group). during a pre-inclusion evaluation period of 4 weeks (non healing) chronicity of ulcer is ensured (ulcer size change of \< 30%). to determine ulcer type abi, doppler and ceap is performed. the test group will receive 2 applications of tiscover®. week 0: wound activating pre-treatment, application of at least one quarter of the wound surface. week 1: removal of patches, application of patches on total wound surface. the control group (16 patients) will follow the same application protocol.

Eligibility criteria:
inclusion criteria: * have a (arterio) venous leg ulcer (vlu) between the knee and ankle (at or above the malleolus), or on foot (not plantar side of the foot) with a surface area ≥ 1.0 cm2 and ≤ 40.0 cm2 * venous insufficiency confirmed by duplex doppler ultrasound examination for valvular or venous incompetence. * arterial supply adequacy confirmed (abpi ≥ 0.6 and ≤ 1.3) * target ulcer involves a full thickness skin loss, but without exposure of tendon, muscle, or bone. ulcer depth \< 1 cm * target ulcer duration ≥ 12 weeks but ≤ 15 years * acceptable state of health and nutrition * mobile, at least able to walk with medical walker, and able to return for required treatments and study evaluations exclusion criteria: * history of anaphylaxis, serum sickness, or erythema multiforme reaction to bovine serum proteins, gentamycin. * therapy with another investigational agent within thirty (30) days of screening, or during the study. * a target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic). * documented history of osteomyelitis at the target wound location within 6 months preceding the screening visit. * refusal of or inability to tolerate compression therapy. * therapy of the target ulcer with autologous skin graft, apligraf™, or dermagraft™ within 30 days preceding the screening visit. * history of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers). * \>30% change of wound size in 4 weeks or confirmed by historical data * presence of deep vein thrombosis or contra indication for compression therapy * severe co-morbidity reducing life expectance to \< 1 year * use of oral corticosteroids and/or cytostatics \>20 mg/per day; * severe infection of ulcer, active cellulitis, osteomyelitis * severe malnutrition * uncontrolled diabetes mellitus, hba1c \> 12% (108 mmol/mol) * anaemia hb \<6 mmol/l
the role of islet glp-1 in the pathogenesis of prediabetes

Conditions: PreDiabetes

Summary: we recently demonstrated that blockade of glucagon-like peptide-1's (glp-1) receptor (glp1r) results in changes in islet function without changes in circulating glp-1. these effects are more pronounced in people with early type 2 diabetes (t2dm) in keeping with increased expression of pc-1/3 and glp-1 that is observed in diabetic islets. however, its regulation is at present unknown. at present it is unknown if these abnormalities develop in prediabetes and whether they contribute to the phenotypes observed. in this experiment we will use blockade of glp1r to probe the contribution of endogenous glp-1 secretion to the regulation of fasting glucose and islet function in prediabetes.

we recently demonstrated that blockade of glucagon-like peptide-1's (glp-1) receptor (glp1r) results in changes in islet function without changes in circulating glp-1. this supports other evidence (rodents and humans) that through the (inducible) expression of a prohormone convertase (pc-1/3), the α-cell can process proglucagon to intact glp-1. 'islet' or 'pancreatic' glp-1 acts in a paracrine fashion to regulate insulin and glucagon secretion. these effects are more pronounced in people with early type 2 diabetes (t2dm). although pancreatic glp-1 adapts to support islet function in t2dm, it is unclear if this mechanism is upregulated in prediabetes and whether it contributes to the phenotype(s) observed. abnormal α-cell responsivity to glucose, measured using g50, is associated with impaired fasting glucose (ifg); β-cell dysfunction is associated with impaired glucose tolerance (igt). does igt (or ifg) represent selective failure of intra-islet glp-1 to support islet function? in this experiment we will use blockade of glp1r to probe the contribution of endogenous glp-1 secretion to the regulation of fasting glucose and islet function in prediabetes

Eligibility criteria:
inclusion criteria: * people with stable weight and no history of diabetes. * fasting glucose \< 126 mg/dl * 2hr glucose after 75g ogtt \< 200 mg/dl exclusion criteria: * age \ 70 years (to avoid studying subjects who could have latent type 1 diabetes, or the effects of age extremes in subjects with normal or impaired fasting glucose). * hba1c \> 6.5% * use of any glucose-lowering agents including metformin or sulfonylureas. * for female subjects: positive pregnancy test at the time of enrollment or study * history of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy. * active systemic illness or malignancy. * symptomatic macrovascular or microvascular disease.

Keywords: impaired fasting glucose impaired glucose tolerance glp-1
surgical treatment for the displaced jakobⅱ classification humerus lateral condylar fractures in children

Conditions: Lateral Condyle Fractures,Humerus,JakobⅡ Classification,Reduction

Summary: multi-center study on surgical treatment for the displaced jakobⅱ classification humerus lateral condylar fractures in children.

the displaced jakobⅱ classification humerus lateral condylar fractures in children that were treated with closed or open reduction.

Eligibility criteria:
inclusion criteria: * patients with fractures that met these criteria, underwent definitive surgery and had complete clinical and radiographic follow up until fracture union at either institution were included in this study. exclusion criteria: * pathologic fractures, and fractures in patients with osteogenesis imperfecta, neuromuscular disorders or any systemic disease that was associated with a predisposition to fractures or altered fracture healing were excluded.
inhaling penehyclidine to prevent perioperative respiratory adverse events in children at risk undergoing sevoflurane anesthesia

Conditions: Respiratory Hypersensitivity; Perioperative Respiratory Adverse Events; Anticholinergics; Inhalation Therapy; Complications; High Risk

Summary: this randomized controlled study is to evaluate the effectiveness of inhaling penehyclidine hydrochloride in reducing perioperative respiratory adverse events in children at risk undergoing minor elective surgery.

children with high risk factors of perioperative respiratory adverse events (praes) remains a challenge for general anesthesia, inhalation of penehyclidine hydrochloride (phc) has been showed to reduce postoperative pulmonary complications and enhance the recovery in high-risk surgical patients. thus, prophylactic phc inhalation might show promising benefits against praes in pediatric anesthesia. this clinical study is designed to test the hypothesis that pediatric patients who exist at least 1 risk factor of praes prophylactically to inhale phc have a lower prevalence of praes.

Eligibility criteria:
inclusion criteria: 1. pediatric patients aged 3 to 7 years. 2. scheduled to undergo ophthalmic surgery. 3. judged to be at risk of praes (with at least one parentally reported risk factor for the praes, including history of a recent cold, wheezing during exercise, wheezing more than three times in the past 12 months, nocturnal dry cough, eczema, or a family history of asthma, rhinitis, eczema, or exposure to passive smoke). exclusion criteria: 1. american society of anesthesiologists (asa) physical classification ≥ iv. 2. known cardiopulmonary diseases (eg. uncorrected congenital heart disease, primary or secondary pulmonary hypertension, tumors, or structural lung diseases). 3. severe renal dysfunction (requirement of renal replacement therapy) or severe hepatic dysfunction (child-pugh grade c); 4. neurological disorders. 5. neuromuscular diseases. 6. contraindication for phc. 7. inhalation of β2-receptor activator, m-receptor blockers and/or glucocorticoids within 1 month before surgery. 8. allergy to anticholinergic drugs. 9. use of endotracheal tube (ett) for ventilation. 10. known difficult airway. 11. severe upper respiratory tract infections (urtis) and the anesthesiologist recommended delaying surgery. 12. participation in other clinical trial during the last month or within the six half-life periods of the study drug used in the last trial. 13. parents refusing to allow their children to participate. 14. obesity, with a body mass index (bmi) over 95th percentile according to the who guideline.

Keywords: perioperative respiratory adverse events pediatric anesthesia penehyclidine sevoflurane
parent-delivered massage for children with autism

Conditions: Autism

Summary: through funding from the u.s. maternal and child health bureau, teaching research institute at western oregon university (wou) will be conducting research on the effect of a parent-delivered massage program on measures of autism and general development in young children with autism. families will participate in an initial training, and receive 24 sessions of ongoing support and training from a trained therapist over the first nine months.

children will be randomly divided into treatment groups and wait-list control groups. the control groups begin treatment five months after the treatment groups begin. all children will be tested on three occasions in the first year: prior to beginning treatment, and five and twelve months later. follow-up testing will be conducted at the end of the second year. results will be shared with parents at the end of each year. testers will remain blinded as to which group is currently receiving treatment. there is no cost to parents for participation in this research study. families meeting the eligibility criteria will be accepted into the study on a first-come, first-served basis.

Eligibility criteria:
inclusion criteria: * have a medical and/or educational diagnosis of autism * be under age 6 * parents willing to attend the parent training session and transport the child to treatment sessions with trained staff 20 times in the first five months * parents willing to give the fifteen-minute massage daily * parents willing not to start any new interventions unless medically necessary exclusion criteria: * taking psychoactive medication or pharmaceutical chelation therapy * additional chronic disability (for example, cerebral palsy or uncontrolled seizures) * receiving more than five hours per week of intensive behavioral treatment for autism (e.g. aba therapy)

Keywords: massage effectiveness autism parent stress
a web-based digital distance visual acuity test

Conditions: Refractive Errors; Low Vision; Vision Disorders

Summary: primary objective of this study is the development and validation of a web-based application for the examination of the distance visual acuity of normal- and low-vision patients.

present study aims to develop and validate a web-based digital distance visual acuity test (democritus distance vision test - ddvit). ddvit is an application, which will be easily accessed through a simple internet connection. this application will provide the possibility of a simple but reliable examination of patients, establishing a commonly accepted way of measuring the distance visual acuity among rural doctors, general practitioners and ophthalmologists. specifically, present study aims to develop a new online distance visual acuity test (ddvit) according to the standards of the early treatment diabetic retinopathy study (etdrs) test and to evaluate the level of agreement between the two visual acuity tests, as well as the test-retest reliability of the online ddvit visual acuity test. the first part of the study is the development of the online visual acuity test (letters, numbers, symbols) including the following smart features: 1. adjustment of the font size according to the size of the computer screen used for the examination 2. real time calculation of the patient-screen distance through a face detection system 3. automatic calculation of the reading time of each line (each logmar) 4. entering the number of patient's reading errors for each line 5. automatic calculation of the visual acuity in the following score units: * number of letters (max 85) * visual acuity score (max 100) * logmar * decimal * snellen fraction the calculation of various reading parameters resulting from the aforementioned features (visual acuity score in different units, reading duration (in sec) and number of errors for each slide (line), patient-screen distance for each slide) will be performed after the end of the examination. except for the html format, a file in the format of microsoft excel and pdf are also generated. the second part of this study is the clinical validation of the ddvit visual acuity test. in this part, the reading acuity measured with the ddvit and etdrs test are compared. all the comparisons will take place in two groups: a) a normal vision group (nvg), and b) a low vision group (lvg) in order to estimate the visual acuity in a population with a wide range of vision.

Eligibility criteria:
inclusion criteria: * patients of our outpatient ophthalmology clinic * age between 18 to 75 years exclusion criteria: * dyslexia * attention-deficiency * former diagnosis of mental and/or psychiatric diseases * inability to cooperate

Keywords: web application distance visual acuity smart features face detection text calibration
association between driving transpulmonary pressure and extravascular lung water in patients with ards

Conditions: Acute Respiratory Distress Syndrome

Summary: intubated patients with the acute respiratory distress syndrome (ards) are usually treated with protective ventilation limiting plateau pressure below 30 centimeter of water (cmh2o) and, if possible, a driving pressure under 15 cmh2o. however, these airway pressures might not reflect the actual pressure applied to the lung. transpulmonary pressure is the difference between airway pressure and pleural pressure, the latter is estimated by the esophageal pressure, and so it better reflects the ventilatory induced lung injury (vili). one of the consequences of the vili is a increase of pulmonary edema and it could be estimated by the extravascular lung water, obtained by trans-pulmonary thermodilution. so it could exist a link between the driving trans-pulmonary pressure and the extravascular lung water.


Eligibility criteria:
inclusion criteria: * acute respiratory distress syndrome (ards) * monitoring with a transpulmonary thermodilution device * esophageal pressure monitoring exclusion criteria: * legal protection measures * pregnancy * contra-indications of esophageal catheter : esophageal varicose, severe coagulopathy
tumor characteristics, pre-transplant treatments and immunosuppression after liver transplantation for hepatocellular carcinoma

Conditions: Liver Transplantation

Summary: recurrence after liver transplantation for hepatocellular carcinoma (hcc) represents an important cause of mortality for this surgical population. in addition to tumor characteristics, it has been suggested that pre-treatment and sirolimus-based immunosuppression may affect recurrence and survival. with data from the european liver transplant registry (eltr) database, the aim of this study is to investigate the impact of tumor characteristics, pre-transplant treatment and immunosuppression regimens on survival after liver transplantation for hcc.


Eligibility criteria:
inclusion criteria: * hepatocellular carcinoma within transplantation criteria exclusion criteria: * disseminated disease
treating binge eating and obesity digitally in black women

Conditions: Binge Eating; Binge-Eating Disorder; Weight Gain Prevention; Obesity

Summary: more than 30% of black women with obesity binge eat. binge eating may increase the risk for the development of metabolic syndrome and binge-eating-disorder (bed), which is associated with severe obesity. though several effective treatments for binge eating exist, black women have not fared well. not only has their inclusion in treatment trials been limited, but when participating, they are more likely to drop out, and/or lose less weight, compared to their white counterparts. furthermore, treatment for binge eating is often not available in primary care and community-based settings places where black women are more likely to receive treatment for their eating and weight-related concerns. currently, there is scant intervention research to treat binge eating in black women. with the highest rates of obesity (57%) nationally, black women are in need of culturally-relevant treatments for binge eating and weight gain prevention. given the established relationship between frequent binge eating and subsequent weight gain, addressing binge eating among black women with obesity is imperative.

aim 1. modify and adapt a validated program to be a culturally-relevant digital health tool for binge eating and weight management for black women (bmi \> 30 kg/m\^2) who binge eat. aim 1a. identify the barriers and facilitators to detecting and treating binge eating in black women with obesity, and identify strategies for optimizing digital health tools to engage and retain this population. aim 1b. conduct usability testing with a group of stakeholders to guide content and design refinements; refine tool. aim 2. in a randomized clinical trial, examine the feasibility and preliminary efficacy of the digital health appetite awareness + behavioral weight program in primary care.

Eligibility criteria:
inclusion criteria: * over 18 years of age, * bmi ≥ 30 kg/m\^2, * have and regularly use a bluetooth-enabled smartphone, * report at least one binge eating episode weekly, * work or live within 30 miles of kannapolis, nc, * complete the screening questionnaire exclusion criteria: * currently pregnant, * in substance abuse treatment, * involved in another weight reduction program, * have a history of anorexia, * are purging, * currently in treatment for eating difficulties, * are concurrent intravenous drug users * consume \>4 alcoholic beverages/day
phase 2b open-label study of inaxaplin in participants with proteinuric apol1 mediated kidney disease

Conditions: Proteinuric Kidney Disease

Summary: the purpose of the study is to evaluate the efficacy, safety, and tolerability of inaxaplin (ixp) in participants with proteinuric apol1- mediated kidney disease (amkd).


Eligibility criteria:
key inclusion criteria: * participant has an apol1 genotype of g1/g1, g2/g2, or g1/g2 obtained with a vertex designated investigational clinical study assay * estimated glomerular filtration rate (egfr) of greater than or equal to (≥) 25 milliliter per minute (ml/min)/1.73m\^2 at screening key exclusion criteria: * evidence of focal segmental glomerulosclerosis (fsgs) with a known cause other than due to apol1 risk variants * uncontrolled hypertension other protocol defined inclusion/exclusion criteria may apply.